Finding studies
Finding studies
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Lead
Istituto Nazionale per lo Studio e la Cura dei Tumori
OBJECTIVES: * Compare the quality of life of patients with stage IIIB or IV non-small cell lung cancer treated with 2 different schedules of docetaxel as second-line therapy. * Compare the toxicity of these regimens in these patients. * Compare the response rate, time to progression, and survival of these patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or complete response vs stable disease vs progressive disease), and prior cisplatin-containing chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a maximum of 6 courses. * Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8 weeks for a maximum of 2 courses. Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and days 22 and 43 for arm II. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
